Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003467
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
1999-11-01
Brief Title:
Carmustine in Treating Adults With Recurrent Supratentorial Low-Grade Glioma
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Phase II Treatment of Adults With Recurrent Supratentorial Low Grade Glioma With Gliadel Wafers
Status:
COMPLETED
Status Verified Date:
2009-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of carmustine in treating adults with recurrent supratentorial low-grade glioma
PURPOSE Phase II trial to study the effectiveness of carmustine in treating adults with recurrent supratentorial low-grade glioma
Detailed Description:
OBJECTIVES
Determine the antitumor activity of Gliadel wafers carmustine in the treatment of recurrent supratentorial low grade glioma
Assess the toxicity of this therapy in these patients
OUTLINE Patients are stratified by disease fibrillary astrocytoma vs oligodendroglioma or mixed glioma
Patients receive up to 8 Gliadel wafers containing carmustine implanted in the resected tumor cavity
Patients are followed every 2 months
PROJECTED ACCRUAL This study will accrue a maximum of 68 patients within 18-24 months
Determine the antitumor activity of Gliadel wafers carmustine in the treatment of recurrent supratentorial low grade glioma
Assess the toxicity of this therapy in these patients
OUTLINE Patients are stratified by disease fibrillary astrocytoma vs oligodendroglioma or mixed glioma
Patients receive up to 8 Gliadel wafers containing carmustine implanted in the resected tumor cavity
Patients are followed every 2 months
PROJECTED ACCRUAL This study will accrue a maximum of 68 patients within 18-24 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000066503 | OTHER | NCI | None |
| DUMC-1706-02-9R5 | None | None | None |
| DUMC-1706-01-9R4 | None | None | None |
| DUMC-000693-00-4 | None | None | None |
| DUMC-1509-97-10 | None | None | None |
| DUMC-1568-98-10R1 | None | None | None |
| DUMC-1706-00-9R3 | None | None | None |
| DUMC-97131 | None | None | None |
| NCI-G98-1470 | None | None | None |